|Indication||PEG-asparaginase is indicated as a component of a multi-agent chemotherapeutic regimen for the first–line treatment of patients with ALL and for the treatment of patients with ALL and hypersensitivity to native forms of L-asparaginase.||ERWINAZE (asparaginase Erwinia chrysanthemi) is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with ALL who have developed hypersensitivity to E. coli-derived asparaginase.|
|Source||E. coli||Erwinia chrysanthemi|
Patients ≤21 years of age
2500 IU/m2 intramuscularly or intravenously no more frequently than every 14 days
Patients >21 years of age
|25,000 IU/m2 administered intramuscularly (IM) or intravenously (IV) 3 times a week for 6 doses for each planned dose of PEG-asparaginase|
|Half-life||Approximately 5.8 days (IM)||0.65 days (IM); 0.31 days (IV)|
Asparaginase therapy is associated with serious adverse events such as hypersensitivity reactions, pancreatitis, glucose intolerance, thrombosis, and hemorrhage2,4
ERWINAZE® (asparaginase Erwinia chrysanthemi) for intramuscular injection (IM) or intravenous infusion (IV), 10,000 International Units (IU)/vial, is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase.
IMPORTANT SAFETY INFORMATION
ERWINAZE is contraindicated in patients with a history of:
- Serious hypersensitivity reactions to ERWINAZE, including anaphylaxis
- Serious pancreatitis with prior L-asparaginase therapy
- Serious thrombosis with prior L-asparaginase therapy
- Serious hemorrhagic events with prior L-asparaginase therapy
Warnings and Precautions
After the use of ERWINAZE in clinical trials, grade 3 and 4 hypersensitivity reactions have occurred in 5% of patients. Administer in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis. If a serious hypersensitivity reaction occurs (including anaphylaxis), discontinue ERWINAZE and initiate appropriate therapy.
In clinical trials, 4% of patients reported pancreatitis with ERWINAZE therapy. Discontinue ERWINAZE for severe or hemorrhagic pancreatitis manifested by abdominal pain >72 hours and amylase elevation ≥2.0 x ULN. In case of mild pancreatitis, hold ERWINAZE until the signs and symptoms subside and amylase levels return to normal. After resolution, ERWINAZE therapy may be resumed.
In clinical trials, 5% of patients reported glucose intolerance, which in some cases may be irreversible. Monitor glucose levels at baseline and periodically during treatment. Administer insulin therapy as necessary in patients with hyperglycemia.
Thrombosis and Hemorrhage
Serious thrombotic events, including sagittal sinus thrombosis, have been reported in both E. coli and Erwinia-derived L-asparaginase therapy. The following coagulation proteins were decreased in the majority of patients after a 2-week course of ERWINAZE by intramuscular administration: fibrinogen, protein C activity, protein S activity, and anti-thrombin III. Discontinue ERWINAZE for a thrombotic or hemorrhagic event until symptoms resolve; after resolution, ERWINAZE therapy may be resumed.
Most Common Adverse Reactions
The most common adverse reactions (incidence 1% or greater) with ERWINAZE treatment are systemic hypersensitivity, hyperglycemia, transaminases abnormal, fever, pancreatitis, local reactions, vomiting, nausea, thrombosis, hyperbilirubinemia, abdominal pain/discomfort, and diarrhea.
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